STA-5326 in Crohn's Disease Patients

June 23, 2005 updated by: Synta Pharmaceuticals Corp.

A Phase I/IIa Trial of STA-5326 in Crohn's Disease Patients With CDAI Scores of 220-450

The purpose of this study is to determine the safety and tolerability of STA-5326 given once daily or twice daily to Crohn's Disease patients with moderate disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Advanced Clinical Therapeutics
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
    • Florida
      • North Miami Beach, Florida, United States, 33162
        • Venture Research Institute, LLC
      • Winter Park, Florida, United States, 32789
        • Shafran Gastoenterology Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Kansas
      • Topeka, Kansas, United States, 66614
        • Heart of America Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Boston, Massachusetts, United States, 02215
        • Brigham and Women's Hospital
    • New York
      • Great Neck, New York, United States, 10021
        • Long Island Clinical Research
      • Rochester, New York, United States, 14607
        • Rochester Institute for Digestive Diseases and Sciences, Inc
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Carolina Research Associates
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Oregon
      • Portland, Oregon, United States
        • West Hills GI
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Blair Gastroenterology Associates
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Memphis Gastroenterology Group
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients 18-65 years old
  • Crohn's Disease for 6 months
  • CDAI scores between 220-450
  • +/- 5-ASA, stable dose for > 2 weeks
  • +/- Corticosteroids, less than or equal to 40 mg per day with a stable dose for 2 weeks
  • +/- Infliximab with no treatment within 4 weeks
  • +/- 6-Mercaptopurine, with a stable dose for 8 weeks
  • +/- Antibiotics, with a stable dose for 2 weeks

Exclusion Criteria:

  • Patients who have had methotrexate, cyclosporine, or other experimental drug within 3 months of screening
  • Pregnancy, breast feeding
  • History of total proctocolectomy with stoma. Previous ileocolectomy would not be a contraindication to the study
  • Bowel obstruction
  • Surgical bowel resection within 90 days
  • Total parenteral nutrition (TPN), CYA, tacrolimus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synta Pharmaceuticals Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Study Completion

November 1, 2004

Study Registration Dates

First Submitted

July 19, 2004

First Submitted That Met QC Criteria

July 20, 2004

First Posted (Estimate)

July 21, 2004

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

May 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5326-03
  • Crohn's Disease
  • CDAI Scores of 220-450

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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